Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT04965857
Status:
UNKNOWN
Last Update Posted:
2023-07-05
First Post:
2021-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner.', 'timeFrame': '1 year', 'description': 'To demonstrate non-inferiority, the appropriate approximative one-sided 95% confidence interval for the true difference between the two approaches (Digital Cytology and Manual microscopic reading) will be constructed.'}], 'secondaryOutcomes': [{'measure': 'To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.', 'timeFrame': '1 year'}, {'measure': 'Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.', 'timeFrame': '1 year', 'description': 'To assess the impact on the workflow of the introduction of a Digital Cytology procedure to a high-throughput screening lab in Germany.'}, {'measure': 'Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.', 'timeFrame': '1 year', 'description': 'The performance of Hologic Genius Digital Cytology Imaging scanner during cervical cancer screening (using histology as reference method) will be assessed via sensitivity, specificity, positive and negative predictive values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer Screening']}, 'descriptionModule': {'briefSummary': 'Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach', 'detailedDescription': "The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to prospectively evaluate the Hologic Genius Digital Cytology (DC) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (LBC) manual microscopic approach. Only anonymized results will be evaluated."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'As part of the German National Cancer Plan, women over the age of 35 years will be given a co-test comprising a Pap smear and an HPV test, every three years.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz \\& Klimas as part of the German Cervical cancer screening program.'}, 'identificationModule': {'nctId': 'NCT04965857', 'briefTitle': 'Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hologic Deutschland GmbH'}, 'officialTitle': 'Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach', 'orgStudyIdInfo': {'id': 'BTS1650_20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Slides from the German Co-Screening program', 'description': 'From 25,000 LBC slides (ThisPrep, Hologic Inc., USA) from the German Co-screening program evaluated using the Genius Digital cytology system all abnormal findings according to Munich III groups (II-p - V) and each 10th normal slide (Munich III group I and II) will be selected for the prospective evaluation by manual microscopy.', 'interventionNames': ["Diagnostic Test: Hologic's Genius Digital Diagnostics System"]}], 'interventions': [{'name': "Hologic's Genius Digital Diagnostics System", 'type': 'DIAGNOSTIC_TEST', 'description': 'Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.', 'armGroupLabels': ['Slides from the German Co-Screening program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40210', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Henrik Griesser, Prof. Dr.', 'role': 'CONTACT', 'email': 'info@zotzklimas.de', 'phone': '+49 (0)221 940 505 840'}], 'facility': 'Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Henrik Griesser, Prof. Dr.', 'role': 'CONTACT', 'email': 'info@zotzklimas.de', 'phone': '+49 (0)221 940 505 840'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hologic Deutschland GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}